American Home Products Corporation v. Finch, Civ. A. No. 3744.
| Decision Date | 18 August 1969 |
| Docket Number | Civ. A. No. 3744. |
| Parties | AMERICAN HOME PRODUCTS CORPORATION, Plaintiff, v. Robert H. FINCH, Secretary of Health, Education and Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Defendants. |
| Court | U.S. District Court — District of Delaware |
William E. Wiggin, Richards, Layton & Finger, Wilmington, Del., Samuel W. Murphy, Jr., Andrew J. Kilcarr, Donovan, Leisure, Newton & Irvine, New York City, of counsel, for plaintiff.
F. L. Peter Stone, U. S. Atty., Wilmington, Del., William W. Goodrich, Asst. Gen. Counsel, U. S. Dept. of Health, Education and Welfare, Washington, D. C., of counsel, for defendants.
FINDINGS OF FACT, CONCLUSIONS OF LAW AND ORDER
This action arises under the Federal Food, Drug and Cosmetic Act. Plaintiff, a manufacturer of certain antibiotic drugs, on July 9, 1969, filed a complaint and motion seeking a preliminary injunction and other relief to stay the defendants' implementation, pending a hearing, of certain orders, the effect of which was to require the plaintiff to recall its drugs from the market by July 23, 1969. On July 16, 1969, the defendants filed affidavits in opposition to plaintiff's motion for injunctive relief and moved to dismiss the complaint or alternatively for summary judgment. The matter came on for hearing on July 22, 1969, at which time the defendants were temporarily restrained from enforcing the orders of defendants pending further order, findings and decision of this Court.
On the basis of the record before this Court, the following findings of fact and conclusions of law are made and entered:
FINDINGS OF FACT
of the Food and Drug Administration ("FDA").
3. Pursuant to § 507(a) of the Food, Drug and Cosmetic Act ("the Act"), 21 U.S.C. § 357(a), which was applicable only to penicillin when first enacted in 1945 and which was later amended in 1947 to include streptomycin, and regulations contained in part 146a of 21 CFR establishing standards of identity, strength, purity and quality for plaintiff's products, FDA has certified batches of each of plaintiff's products to be safe and effective for the uses indicated in its labeling (including "package inserts") for periods beginning in 1954, 1953, 1952, and 1956, respectively, in the sequence as listed in paragraph 2.
4. A total of 569 batches have been so certified,1 each certification representing a determination by the Commissioner that the drug certified is safe and effective. The last such certification, involving a batch of Bicillin-Sulfas, Suspension, was on April 23, 1969.
5. In 1962 Congress amended §§ 505 and 507 of the Act. Section 505 (21 U.S.C. § 355) requires manufacturers of "new drugs", other than antibiotics covered by § 507, to file with FDA a new drug application. The 1962 amendments required for the first time that new drug applications be supported by "substantial evidence" of their efficacy. Section 507 was amended to expand its coverage to include "other antibiotics" than those previously specified therein (which specification included penicillin and streptomycin), to add a definition of "antibiotic", to impose certain reporting requirements, and to provide for the possible future coverage under § 507 of "other antibiotics" previously covered under § 505. The certification provisions of § 507(a), however, pursuant to which plaintiff's products had been continuously certified as effective and safe, were not amended.
6. In 1966 the then Commissioner undertook to evaluate the efficacy of all drugs, marketed under new drug applications which became effective between 1938 and October 10, 1962, under § 505 as safe and to re-evaluate the efficacy of antibiotic drugs previously certified as safe and effective pursuant to § 507, including plaintiff's drugs, and contracted with the National Academy of Sciences — National Research Council to conduct said evaluation and re-evaluation.
7. On October 6, 1966, the Commissioner caused to be published in the Federal Register an order requiring manufacturers of drugs certified pursuant to § 507 to submit certain data to FDA within thirty days, such data to be utilized in connection with the NAS/NRC drug review aforementioned.2 Plaintiff complied with this request on October 31, 1966 with respect to its products involved in this case, without, however, waiving its right to dispute the authority of FDA to require the submission of such data for such purpose.
8. Defendants received the NAS/NRC's reports on plaintiff's drugs in or about September, 1968. The reports concluded that plaintiff's penicillin-streptomycin products were "ineffective as fixed combinations". The basis of such conclusions appears to be a determination that plaintiff's drugs are not relatively more effective than their individual components used separately, or than other antibiotics.
9. The reports acknowledge that simultaneous uses of penicillin and streptomycin or penicillin and sulfanomide are effective for certain diseases and infections.
10. Prior to initiation of the NAS/NRC study, public conferences were held between representatives of NAS/NRC, FDA, the medical profession and the drug industry, and public statements by FDA representatives were made concerning the then proposed study, and guidelines for the study were laid down. Throughout these conferences and until December 24, 1968, plaintiff had no reason to believe that a finding of "ineffective as a fixed combination" would be made. Rather, plaintiff was led to believe that findings would be limited to "effective, probably effective, possibly effective, or ineffective". Plaintiff was not informed until April 2, 1969 that the evidence upon which FDA had certified its drugs for many years was inadequate, or that long clinical experience with a drug would not be considered important evidence of efficacy — that is, of substantially equivalent weight as the type of controlled clinical studies now required in respect of new drugs. In addition, it had some reason to believe, until April 2, 1969, that a hearing would be held before any drug was removed from the market by FDA for lack of evidence of efficacy.
11. On April 2, 1969, at least six months after receiving NAS/NRC's reports, the Commissioner caused to be published in the Federal Register (34 Fed.Reg. 6006-07) notices of intention to amend FDA regulations so as to delete plaintiff's products from the list of drugs acceptable for certification pursuant to § 507. The Commissioner stated in those notices that he "concurred" in the findings by NAS/NRC that plaintiff's products were "ineffective" or "ineffective as fixed combinations" and that there is a "lack of substantial evidence" supporting the efficacy of these combinations. The notices invited plaintiff to submit "pertinent data". No mention was made of a hazard of any kind.
12. On May 1, 1969 plaintiff submitted such data and requested a hearing. The submission was in four parts: a general examination of the uses of antibiotic combinations, based upon both theoretical and practical considerations; a discussion of the uses of penicillin-streptomycin combinations, commenting briefly on the NAS/NRC reports and citing numerous scientific studies; a similar discussion of penicillin sulfanomide combinations; and an examination of the legal validity of the Commissioner's intended action.
13. On June 13, 1969 the Commissioner caused to be published in the Federal Register Orders deleting plaintiff's products from the list of antibiotic drugs eligible for certification, prohibiting all further certification, and revoking previously issued certificates. The reasons stated by the Commissioner for these actions were that plaintiff's May 1, 1969 submission did not contain any "new clinical data", did not "provide substantial evidence of the effectiveness of such combination drugs", that "there are known hazards associated with the use of each component of such combination", and that the use of each product involved an "unwarranted hazard". This was the first mention of such a hazard and FDA has never suggested at any time that plaintiff's drugs involved an "imminent hazard".
14. The June 13th Orders provided that objections thereto could be submitted and a hearing requested within thirty days, but that withdrawal of the products from the market must be completed within forty days. The Orders also state that "a statement of reasonable grounds for a hearing must identify the claimed errors in the NAS/NRC evaluation and identify any adequate and well-controlled investigations on the basis of which it would reasonably be concluded that the combination drugs would have the effectiveness claimed and would be safe for their intended use". Plaintiff submitted objections within the thirty-day period, on July 9, 1969, and again requested a hearing. The Commissioner has not yet ruled on these objections or on the request.
15. The Commissioner has stated publicly...
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